The Relationship of Hemoglobin A1c and Diabetic Wound Healing

Phase 4

Terminated

• Conditions: Diabetes, Type 2; Diabetes, Type 1; Foot Ulcer, Diabetic
• Interventions: Drug: AmeriGel®; Drug: Bacitracin; Dietary Supplement: Vitamin C

• Registration Number: NCT01350102
• Lead Sponsor: Susan Hassenbein

Brief Summary

The purpose of this study is to investigate the relationship of hemoglobin A1c in diabetic wound healing. Additionally, a comparison of two wound dressings, AmeriGel® (Amerx Health Care Corp., Clearwater, FL) and Bacitracin, with and without vitamin C supplementation, will be done to evaluate impact on time to wound closure.

Detailed Description

This is a prospective randomized controlled study evaluating the relationship of hemoglobin A1c in diabetic wound healing. Length of time for wound closure will be compared using four treatment options.

Study Timeline

• Study First Submitted: 2011-05-04
• Study First Submitted QC: 2011-05-06
• Study First Posted: 2011-05-09
• Study Start: 2012-02
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Disposition First Submitted: 2015-04-14
• Disposition First Submitted QC: 2015-05-06
• Disposition First Posted: 2015-05-25
• Results First Submitted: 2017-06-28
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-13
• Last Update Submitted: 2017-11-13
• Results First Posted: 2017-12-12
• Last Update Posted: 2017-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• >18 years of age
• Diabetic (Type I and Type II)
• Ulceration of the foot at least one centimeter in width/length
• Ulceration at least 0.2 centimeters in depth

Exclusion Criteria

• Ulceration width/length > 7.5 centimeters
• Wound depth > 1.25 centimeters
• Purulent, excessive drainage and/or other signs of infection (i.e. erythema, edema, warmth)
• Inability to provide informed consent
• Inability to swallow pills (vitamin C supplement)
• Patients with concurrent renal problems
• Patients with medication contraindications to Vitamin C and/or topical wound dressings

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bacitracin with Vit C	Vitamin C	Bacitracin wound care dressing with Vitamin C supplementation
AmeriGel® with Vit C	Vitamin C	AmeriGel® wound care dressing with Vitamin C supplementation
AmeriGel® wound care dressing alone	AmeriGel®	AmeriGel® wound care dressing alone
AmeriGel® with Vit C	AmeriGel®	AmeriGel® wound care dressing with Vitamin C supplementation
Bacitracin wound care dressing alone	Bacitracin	Bacitracin wound care dressing alone
Bacitracin with Vit C	Bacitracin	Bacitracin wound care dressing with Vitamin C supplementation

Primary Outcome Measures

Name	Time	Method
Hgb A1c Level	Patients are assessed every 3 months from enrollment through end of study participation, which may be 6 months	Hgb A1c measures the average blood glucose over three months (% of hemoglobin). All subjects will be asked to get their hemoglobin A1c level at the beginning of the study and every three months for as long as they participate in the study.

Secondary Outcome Measures

Name	Time	Method
Length of Time for Wound Closure	Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months	Length of time for wound closure will be measured in days
Wound Area Measurements	Patients are assessed every other week (bi-weekly) until 100% wound healing is achieved, which may take up to 6 months	Wound area measurements in length, width, and depth throughout the course of the study(measured in cm).

Trial Locations

Locations (1)

Penn State Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States